Recruiting NCT06319820

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Phase III Interventional Non-Muscle Invasive Bladder Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: TAR-210, Gemcitabine, MMC.
Who it may be relevant to: Registry conditions: Non-Muscle Invasive Bladder Neoplasms. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Austria, Belgium, Brazil +15
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations

Overview

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Interventions

Combination product TAR-210
TAR-210 will be administered intravesically.
Drug Gemcitabine
Gemcitabine will be administered intravesically.
Drug MMC
MMC will be administered intravesically.

Primary outcome measures

Disease Free Survival (DFS) [Time frame: From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)]

Secondary outcome measures (10)

Time to next Treatment (TTNT) [Time frame: From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)]
High Grade Recurrence-free Survival (HG RFS) [Time frame: From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)]
Progression Free Survival (PFS) [Time frame: From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)]
Number of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment [Time frame: From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)]
Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities) [Time frame: From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)]
Overall Survival (OS) [Time frame: From randomization to the date of death (approximately 4 years and 2 months)]
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores [Time frame: Baseline, Weeks 6, 12, 24, 36, and 48]
European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores [Time frame: Baseline, Weeks 6, 12, 24, 36, and 48]
Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores [Time frame: Weeks 6, 12, 24, 36, and 48]
Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores [Time frame: Weeks 6, 12, 24, 36, and 48]

Eligibility criteria

Inclusion criteria

Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor >= 3 cm, iii. Early recurrence (less than \[<\] 1 year), iv. Frequent recurrence (greater than \[>\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and >=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor >=3 cm
Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.
Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
Have an Eastern Cooperative Oncology Group performance status of 0 to 2

Exclusion criteria

Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs
Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy
Polyuria with recorded 24-hour urine volumes > 4000 milliliters (mL)
Current indwelling urinary catheters, however, intermittent catheterization is acceptable
Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)

Substudy:

\- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 38 centers

Arkansas Urology — Little Rock
Genesis Research LLC — Los Alamitos
USC Norris Comprehensive Cancer Center — Los Angeles
University of California Irvine Medical Center — Orange
Om Research LLC — San Diego
Genesis Research LLC 1 — Sherman Oaks
University of Colorado Cancer Center Anschultz Cancer Pavilion — Aurora
Colorado Clinical Research — Lakewood
… and 30 more centers

China · 17 centers

Beijing Friendship Hospital Capital Medical University — Beijing
Peking University Third Hospital — Beijing
Hunan Cancer hospital — Changsha
The Third People's Hospital of Chengdu — Cheng Du Shi
West China School of Medicine/West China Hospital, Sichuan University — Cheng Du Shi
Chongqing Cancer Hospital — Chongqing
Fujian Medical University Union Hospital — Fuzhou
Sun Yat Sen University Cancer Center — Guangzhou
… and 9 more centers

Spain · 16 centers